Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000333516
Ethics application status
Approved
Date submitted
22/07/2006
Date registered
7/08/2006
Date last updated
3/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Ant Venom Immunotherapy: Improving method and maintenance.
Scientific title
A randomised 2x2 comparison of ultra-rush with semi-rush initiation, and 50 microgram versus 100 microgram maintenance venom immunotherapy for preventing anaphylaxis in jack jumper ant venom allergic people.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy (anaphylaxis) to the jack jumper ant (JJA) 1302 0
Myrmecia pilosula. 1303 0
Condition category
Condition code
Inflammatory and Immune System 1393 1393 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Venom immunotherapy by subcutaneous injection; randomised 2 x 2 factorial design; ultra-rush (treatment initiation over 2 days) versus semi-rush (treatment initiation over 10 weeks), and 50 mcg versus 100 mcg maintenance dosing every three months for 3-5 years. A patient's choice arm is also available for part of the study where the patient may select either or both of initiation method and maintenance dose.
Intervention code [1] 1221 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Active

Outcomes
Primary outcome [1] 1897 0
Systemic reaction rates to immunotherapy during treatment initiation.
Timepoint [1] 1897 0
3 visits (3 weeks) in ultra-rush and 10 visits (10 weeks) in semi-rush respectively.
Primary outcome [2] 1898 0
Systemic reaction rates to sting challenge.
Timepoint [2] 1898 0
After 12-15 months of maintenance therapy.
Secondary outcome [1] 3356 0
Systemic reaction rates to immunotherapy during treatment initiation and to deliberate sting challenges in the patient choice arms.
Timepoint [1] 3356 0
Definition of "treatment initiation" changed to 3 visits (3 weeks) in ultra-rush and 10 visits (10 weeks) in semi-rush respectively.
Secondary outcome [2] 3357 0
Number of visits and total dose of venom extract up until sting challenge.
Timepoint [2] 3357 0
12-15 months
Secondary outcome [3] 3358 0
Time interval from treatment initiation to achieving 1 month, 2 month and 3 month dosing intervals.
Timepoint [3] 3358 0
Measured over 12-15 months
Secondary outcome [4] 3359 0
Reactions to accidental field stings over duration of treatment (3-5 years) and during long term follow up after stopping immunotherapy (10 years).
Timepoint [4] 3359 0
10 years

Eligibility
Key inclusion criteria
Adults and children with a history of one or more systemic allergic reactions to a known or suspected JJA sting.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Negative intradermal skin and serum (RAST) tests for venom-specific IgE; pregnancy at time of treatment initiation; psychiatric illness rendering the patient unable to understand the study; severe cardiac or respiratory disease such that there is a high risk of decompensation to the mild-moderate allergic reactions that commonly occur with immunotherapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of treatment initiation method is not concealed, however the dose given will be single-blind (treating staff will be aware of dose, but the patient will not be told).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
A "patient choice arm" is also provided so that patients may choose the initiation method and maintenance dose.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1527 0
Government body
Name [1] 1527 0
Department of Health and Human Services, Tasmanian Government
Country [1] 1527 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Human Services, Tasmanian Government
Address
GPO Box 125
HOBART TAS 7001
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 1341 0
University
Name [1] 1341 0
University of Western Australia
Address [1] 1341 0
Crawley, Western Australia
Country [1] 1341 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2949 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK -Royal Hobart Hospital
Ethics committee address [1] 2949 0
Ethics committee country [1] 2949 0
Australia
Date submitted for ethics approval [1] 2949 0
Approval date [1] 2949 0
21/07/2006
Ethics approval number [1] 2949 0
H0008934.
Ethics committee name [2] 2950 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK -Launceston General Hospital
Ethics committee address [2] 2950 0
Ethics committee country [2] 2950 0
Australia
Date submitted for ethics approval [2] 2950 0
Approval date [2] 2950 0
21/07/2006
Ethics approval number [2] 2950 0
H0008934.
Ethics committee name [3] 2951 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK -North West Regional Hospital
Ethics committee address [3] 2951 0
Ethics committee country [3] 2951 0
Australia
Date submitted for ethics approval [3] 2951 0
Approval date [3] 2951 0
21/07/2006
Ethics approval number [3] 2951 0
H0008934.

Summary
Brief summary
The objectives of this study are to improve the delivery of venom immunotherapy (VIT) by assessing the efficacy and safety of different approaches to venom immunotherapy, namely ultra-rush (ultra-rapid initiation over 2 days) versus semi-rush (initiation over 10 weeks) and half-dose (50 microgram) versus standard dose (100 microgram) maintenance treatment.

Specific hypotheses are that: (i) ultra-rush initiation will be equivalent to outpatient semi-rush initiation in terms of allergic reaction rates to immunotherapy; (ii) A maintenance dose of 50 mcg will be as efficacious as a 100 mcg maintenance dose, and; (iii) VIT with both initiation methods and maintenance doses will have a sustained positive impact (reduced reaction risk) after cessation of VIT.

The study will have important implications. If the different approaches are equivalent, we will be able to significantly reduce the amount of venom extract used and thus increase the number of patients that we can treat, given that our venom supplies are expensive and limited.

Because it will be impossible to conceal treatment allocations, the different initiation methods will be unblinded. Maintenance doses will be single blinded (known to the treating doctor but not the patient) because of the significant day-to-day dose adjustments required during immunotherapy would make double-blinding difficult and potentially dangerous.

The main outcome measures will be (1) the occurence of systemic allergic reactions to immunotherapy (safety of treatment) and (2) systemic allergic reactions to deliberate sting challenges and accidental stings (effectiveness of treatment)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35933 0
Address 35933 0
Country 35933 0
Phone 35933 0
Fax 35933 0
Email 35933 0
Contact person for public queries
Name 10410 0
Associate Professor Simon G A Brown
Address 10410 0
University of Western Australia
Discipline of Emergency Medicine
(M516) 2nd Floor R Block
QE11 Medical Centre
Nedlands WA 6009
Country 10410 0
Australia
Phone 10410 0
+61 419796678
Fax 10410 0
Email 10410 0
[email protected]
Contact person for scientific queries
Name 1338 0
Associate Professor Simon G A Brown
Address 1338 0
University of Western Australia
Discipline of Emergency Medicine
(M516) 2nd Floor R Block
QE11 Medical Centre
Nedlands WA 6009
Country 1338 0
Australia
Phone 1338 0
+61 419796678
Fax 1338 0
Email 1338 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFactors influencing the quality of Myrmecia pilosula (Jack Jumper) ant venom for use in in vitro and in vivo diagnoses of allergen sensitization and in allergen immunotherapy.2017https://dx.doi.org/10.1111/cea.12987
EmbaseTowards complete identification of allergens in Jack Jumper (Myrmecia pilosula) ant venom and their clinical relevance: An immunoproteomic approach.2018https://dx.doi.org/10.1111/cea.13224
N.B. These documents automatically identified may not have been verified by the study sponsor.